title: Irbesartan in patients with atrial fibrillation.
abstract: BACKGROUND
  The risk of cardiovascular events among patients with atrial fibrillation is high. We evaluated whether irbesartan, an angiotensin-receptor blocker, would reduce this risk.
  
  
  METHODS
  We randomly assigned patients with a history of risk factors for stroke and a systolic blood pressure of at least 110 mm Hg to receive either irbesartan at a target dose of 300 mg once daily or double-blind placebo. These patients were already enrolled in one of two trials (of clopidogrel plus aspirin versus aspirin alone or versus oral anticoagulants). The first coprimary outcome was stroke, myocardial infarction, or death from vascular causes; the second was this composite outcome plus hospitalization for heart failure.
  
  
  RESULTS
  A total of 9016 patients were enrolled and followed for a mean of 4.1 years. The mean reduction in systolic blood pressure was 2.9 mm Hg greater in the irbesartan group than in the placebo group, and the mean reduction in diastolic blood pressure was 1.9 mm Hg greater. The first coprimary outcome occurred at a rate of 5.4% per 100 person-years in both groups (hazard ratio with irbesartan, 0.99; 95% confidence interval [CI], 0.91 to 1.08; P=0.85). The second coprimary outcome occurred at a rate of 7.3% per 100 person-years among patients receiving irbesartan and 7.7% per 100 person-years among patients receiving placebo (hazard ratio, 0.94; 95% CI, 0.87 to 1.02; P=0.12). The rates of first hospitalization for heart failure (a prespecified secondary outcome) were 2.7% per 100 person-years among patients receiving irbesartan and 3.2% per 100 person-years among patients receiving placebo (hazard ratio, 0.86; 95% CI, 0.76 to 0.98). Among patients who were in sinus rhythm at baseline, there was no benefit of irbesartan in preventing hospitalization for atrial fibrillation or atrial fibrillation recorded on 12-lead electrocardiography, nor was there a benefit in a subgroup that underwent transtelephonic monitoring. More patients in the irbesartan group than in the placebo group had symptomatic hypotension (127 vs. 64) and renal dysfunction (43 vs. 24).
  
  
  CONCLUSIONS
  Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation. (Funded by Bristol-Myers Squibb and Sanofi-Aventis; ClinicalTrials.gov number, NCT00249795.).
authors.affiliation: Population Health Research Institute, McMaster University, Hamilton, ON, Canada.
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
authors.forename: Janice
authors.initials: J
authors.lastname: Pogue
authors.forename: Susan
authors.initials: S
authors.lastname: Chrolavicius
authors.forename: Marcus
authors.initials: M
authors.lastname: Flather
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hart
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.forename: Campbell D
authors.initials: CD
authors.lastname: Joyner
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
mesh_terms: D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000517:prevention & control; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D006333:Heart Failure / Q000517:prevention & control; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D000077405:Irbesartan; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000517:prevention & control*; D012307:Risk Factors; D055502:Secondary Prevention; D020521:Stroke / Q000401:mortality / Q000517:prevention & control*; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D014652:Vascular Diseases / Q000401:mortality
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001713:Biphenyl Compounds; D013777:Tetrazoles; D000077405:Irbesartan